Safety & PV Specialist I | Explore Top Pharmacovigilance Jobs in India
Start your journey with one of the most rewarding Pharmacovigilance Jobs in the industry by applying for the Safety & PV Specialist I role at Syneos Health. This opportunity is perfect for professionals seeking growth-focused Syneos Health Careers and highly competitive PV Jobs in India across locations such as Gurugram, Hyderabad, and Pune. Step into a global biopharma environment where your skills in drug safety and compliance can directly impact patient lives.
Job Details:
- Job Title: Safety & PV Specialist I
- Remote Type: Office-based
- Locations: IND-Gurugram, IND-Hyderabad, IND-Pune
- Job Requisition ID: 25102713
About the Company:
Syneos Health® is a leading, fully integrated biopharmaceutical solutions organization built to accelerate customer success. With over 29,000 employees across 110 countries, it blends clinical, medical affairs, and commercial insights to address evolving market needs. The company’s Total Self culture ensures employees can be authentically themselves while contributing to global healthcare transformation — making it a top choice for those seeking Syneos Health Careers, Pharmacovigilance Jobs, and PV Jobs in India.
Job Description | Pharmacovigilance Jobs
The Safety & PV Specialist I role supports global pharmacovigilance operations, ensuring all safety data is processed, coded, tracked, and reported accurately. This is an excellent position for individuals aiming to grow within Pharmacovigilance Jobs, advance in PV Jobs in India, and build long-term Syneos Health Careers.
Key Responsibilities At Pharmacovigilance Jobs:
- Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required.
- Assists in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required.
- Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory reportability.
- Enters data into safety database. Codes events, medical history, concomitant medications, and tests.
- Compiles complete narrative summaries. Identifies information to be queried and follows up until information is obtained and queries are satisfactorily resolved.
- Assists in the generation of timely, consistent, and accurate reporting of expedited reports in accordance with applicable regulatory requirements.
- Maintains safety tracking for assigned activities.
- Performs literature screening and review for safety, drug coding, maintenance of drug dictionary, MedDRA coding as required.
- Validation and Submission of xEVMPD product records, including appropriate coding of indication terms using MedDRA.
- Manual recoding of un-recoded product and substance terms arises from ICSRs.
- Identification and management of duplicate ICSRs.
- Activities related to SPOR / IDMP.
- Quality review of ICSRs.
- Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate.
- Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCP, ICH guidelines, GVP, project/program plans and the drug development process.
- Fosters constructive and professional working relationships with all project team members, internal and external.
- Participates in audits as required/appropriate.
- Applies safety reporting regulatory intelligence maintained by Syneos Health to all safety reporting activities.
Qualifications:
- Bachelor’s Degree in life science, registered nurse, pharmacist or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills, and abilities to perform the job.
- Safety Database systems and knowledge of medical terminology required.
- Good understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements, ICH GCP, GVP and regulations related to Safety and Pharmacovigilance.
- Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), Team Share (or another management/shared content/workspace) and internet.
- Ability to work independently and in a team environment.
- Excellent communication and interpersonal skills, both written and spoken.
- Good organizational skills with proven ability to prioritize and work on multiple tasks and projects.
- Detail oriented with a high degree of accuracy and ability to meet deadlines.
